Please enjoy a quick update for selected new FDA approvals

1. A MONTHLY
DOSE OF EDUCATION
Brian Pelletier, PharmD, BCGP, FASCP
CEO, A Dose of Education, LLC
May 2017

2. FDA Approval
• Tymlos® (abaloparatide) – approved 4/28/2017
• Indicated for the treatment of postmenopausal women with osteoporosis
at high risk for fracture
• Formulation / Administration
• Recommended dose is 80 mcg subcutaneously once daily; patients
should receive supplemental calcium and vitamin D if dietary intake is
inadequate
• Administer as a subcutaneous injection into periumbilical region of
abdomen (rotating sites of administration)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf#page=18

3. Tymlos® (abaloparatide)
• Available as single patient use pre-filled pen
• Store in refrigerator prior to use. After first use, stable for 30 days at RT
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf#page=18

4. FDA Approval
• Ingrezza® (valbenazine) – approved 4/11/2017
• Vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the
treatment of adults with tardive dyskinesia
• Formulation / Administration
• Available in 40mg capsules: The initial dose is 40 mg once daily. After
one week, increase the dose to the recommended dose of 80 mg once
daily
• Can be taken with or without food
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf

5. Ingrezza® (valbenazine)
• Precautions
• For patients with moderate or severe hepatic impairment, recommended
dose is 40 mg once daily
• Consider dose reduction based on tolerability in known CYP2D6 poor
metabolizers
• Avoid concomitant use with MAOIs
• Avoid use with strong CYP3A4 inducers
• Reduce dose with strong CYP3A4/CYP2D6 inhibitors
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf

6. FDA Approval
• Symproic® (naldemedine) – approved 3/23/2017
• Opioid antagonist indicated for the treatment of opioid- induced
constipation (OIC) in adult patients with chronic non-cancer pain
• Formulation / Administration
• Recommended dosage is 0.2 mg once daily with or without food
• Drug Interactions
• Strong CYP3A inducers (e.g., rifampin): Decreased naldemedine
concentrations; avoid concomitant use
• Other opioid antagonists: Potential for additive effect and increased risk
of opioid withdrawal; avoid concomitant use
• Moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A4
inhibitors
• P-gp inhibitors (e.g., cyclosporine)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf#page=13

7. FDA Approval
• Xadago® (safinamide) – approved 3/21/2017
• Monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive
treatment to levodopa/carbidopa in patients with Parkinson’s disease
(PD) experiencing “off” episodes
• Formulation / Administration
• 50mg and 100mg tablets available
• Start with 50 mg administered orally once daily at the same time of day;
after two weeks, the dose may be increased to 100mg once daily, based
on individual need and tolerability
• Hepatic Impairment: Do not exceed 50 mg once daily in patients with
moderate hepatic impairment; contraindicated in patients with severe
hepatic impairment
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf

8. Thank you!